Miscarriage Preventing Herbal Medicines and the Risk of Birth Defects: a Population-based Cohort Study

Pregnancy Clinical Trial

Official title:

Miscarriage Preventing Herbal Medicines and the Risk of Birth Defects: a Population-based Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06048276
• Other study ID #: HERB and BD
• Status: Active, not recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Using data from a population-based medicine use cohort in Xiamen, China, this retrospective cohort study will investigate whether herbal medicines used to prevent miscarriage are associated with increased risk of birth defects.

Description:

Herbal medicines have a long history of use for pregnant women both in China and around the world. However, the safety of herbal medicines used at the early gestation is often questioned regarding their impact on offspring. Therefore, the aim of this study is to investigate whether miscarriage preventing herbal medicines associated with increased risk of birth defects.

A large medication use cohort will be developed by linking a population-based pregnancy registry (i.e., REPRESENT) and a population-based pharmacy database, which documented all prescriptions at both outpatients and inpatients from conception to delivery. This cohort will include herbal medicines formula which were granted approval by the Chinese National Medical Products Administration.

Using data from this cohort, the investigators will investigate the prevalence of the use of herbal medicine formulas and prescription patterns at the first trimester. This study will then investigate the association between miscarriage preventing herbal medicines and the risk of birth defects. A propensity score matching (PSM) based Poisson regression will be used to estimate the relative risk. To ensure the robustness of the results investigators will perform several sensitivity analyses and negative control analyses, such as restricting the population to women with singleton pregnancies, excluding individuals who had undergone in vitro fertilization (IVF), and considering those women who were prescribed herbal medicines during the middle and late stages of pregnancy as the negative exposure control group.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200000
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• Pregnancies registered at REPRESENT and underwent live births between January 2013 and December 2018 were included.

Exclusion Criteria:

• (1) those with the first antenatal visit occurring after 20 gestational weeks, (2) those without timing records of the last menstrual period or delivery dates, (3) those with known factors related to birth defects (e.g.,syphilis positive, epilepsy), (4) those prescribed known medications associated with birth defects (e.g.,dezocine, diazepam).

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Birth Defects
• Congenital Abnormalities
• Pregnancy

Intervention

Drug:
• Herbal medicines (e.g., Yunkang granules, Duzhong granules)
Herbal medicines (e.g., Yunkang granules, Duzhong granules) exposure at the early gestation.

Locations

Country	Name	City	State
China	Xiamen Health and Medical Big Data Center	Xiamen	Fujian

Sponsors (3)

Lead Sponsor	Collaborator
West China Hospital	Xiamen Health and Medical Big Data Center, Xiamen Health Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall birth defects (excluding chromosomal malformations)	Number of births with birth defects	From conception to 42 days after delivery
Secondary	National monitored 23 main types of birth defects	Number of births with 23 major births defects defined by National Health Standard Criteria in the China national universal surveillance system	From conception to 42 days after delivery